Elecsys Troponin T STAT Assay 4660307190Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04015630921621), received between Aug 17, 2018 and Apr 14, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “High Test Results” (3 reports).

4 other recalls cover devices cleared under the same FDA submission (K082699); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2023Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TROPONIN T STAT ASSAY ON COBAS 6000 E601 MODULE SERIAL NUMBER (B)(4). THE SAMPLE INITIALLY RESULTED IN A TROPONIN T VALUE OF 80.56 NG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. A SECOND SAMPLE COLLECTED FROM THE PATIENT RESULTED IN A TROPONIN T VALUE OF 9.10 NG/ML, SO THE DOCTOR QUESTIONED THE INITIAL VALUE FROM THE COMPLAINED SAMPLE. THE SAMPLE WAS REPEATED TWICE ON THE SAME ANALYZER, RESULTING IN TROPONIN T VALUES OF 14.89 NG/ML AND 17.37 NG/ML. THE 14.89 NG/ML VALUE WAS DEEMED CORRECT. THE SAMPLE WAS ALSO REPEATED ON A SECOND E601 ANALYZER (UNKNOWN SERIAL NUMBER), RESULTING IN A TROPONIN T VALUE OF 18.66 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16746183 ↗
• MalfunctionFeb 28, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR FIVE PATIENT SAMPLES TESTED WITH THE ELECSYS TROPONIN T HS STAT ASSAY ON A COBAS E 411 ANALYZER (DISK SYSTEM). PATIENT SAMPLE 1: THE SAMPLE INITIALLY RESULTED IN A TROPONIN T HS STAT VALUE OF 23.86 PG/ML. THE SAMPLE WAS REPEATED THREE TIMES, RESULTING IN VALUES OF 11.19 PG/ML, 35.52 PG/ML AND 37.43 PG/ML. THE RESULT DEEMED CORRECT WAS 8.3 NG/L. PATIENT SAMPLE 2: THE SAMPLE INITIALLY RESULTED IN A TROPONIN T HS STAT VALUE OF 18.6 PG/ML. THE SAMPLE WAS REPEATED THREE TIMES, RESULTING IN VALUES OF 27.9 PG/ML, 12.9 PG/ML, AND 19.6 PG/ML. IT IS UNKNOWN WHICH RESULT WAS DEEMED CORRECT. PATIENT SAMPLE 3: THE SAMPLE INITIALLY RESULTED IN A TROPONIN T HS STAT VALUE OF 27.85 PG/ML AND REPEATED AS 12.91 PG/ML. THE RESULT DEEMED CORRECT WAS 78.8 NG/L PATIENT 4: THE SAMPLE INITIALLY RESULTED IN A TROPONIN T HS STAT VALUE OF 16.62 PG/ML. THE RESULT DEEMED CORRECT WAS 8.6 NG/L. PATIENT 5: THE SAMPLE INITIALLY RESULTED IN A TROPONIN T HS STAT VALUE OF 12.25 PG/ML AND REPEATED AS 21.86 PG/ML. THE RESULT DEEMED CORRECT WAS 12.5 NG/L. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. IT WAS ASKED BUT IT IS UNKNOWN IF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16454133 ↗
• MalfunctionDec 6, 2022High Test Results; Insufficient Device Problem Information; Non Reproducible Results; High Test Results; Insufficient Device Problem Information; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TROPONIN T STAT ASSAY RESULTS FROM FIVE PATIENT SAMPLES TESTED ON THE COBAS 6000 E601 MODULE. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT SAMPLES WERE RERUN ON THEIR OTHER E 601. THE REPEAT RESULTS WERE REPORTED TO BE LESS THAN THE LEVEL OF DETECTION WHICH IS 0.010 NG/ML. ON (B)(6) 2022: SAMPLE (B)(6)- THE INITIAL RESULT FROM THE MODULE WAS 0.035 NG/ML. THE REPEAT RESULT WAS LESS THAN THE LEVEL OF DETECTION OF 0.010 NG/ML. ON (B)(6) 2022: SAMPLE (B)(6)- THE INITIAL RESULT FROM THE MODULE WAS 0.036 NG/ML. THE REPEAT RESULT WAS LESS THAN THE LEVEL OF DETECTION OF 0.010 NG/ML. SAMPLE (B)(6)- THE INITIAL RESULT FROM THE MODULE WAS 0.89 NG/ML. THE REPEAT RESULT WAS LESS THAN THE LEVEL OF DETECTION OF 0.010 NG/ML. ON (B)(6) 2022: SAMPLE (B)(6)- THE INITIAL RESULT FROM THE MODULE WAS 0.024 NG/ML. THE REPEAT RESULT WAS LESS THAN THE LEVEL OF DETECTION OF 0.010 NG/ML. ON AN UNSPECIFIED DATE: SAMPLE (B)(6) - THE INITIAL RESULT FROM THE MODULE WAS 1.8 NG/ML. THE REPEAT RESULT WAS LESS THAN THE LEVEL OF DETECTION OF 0.010 NG/ML. THE REPEAT RESULTS WERE DEEMED CORRECT. THE REAGENT LOT NUMBER AND THE EXPIRATION DATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15926317 ↗
• MalfunctionJan 26, 2022Incorrect Measurement; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TROPONIN T STAT ASSAY RESULTS NOT CORRESPONDING TO THE CLINICAL PICTURE FOR TWO SAMPLES FROM ONE PATIENT TESTED ON THE COBAS 8000 - COBAS E 602 MODULE WITH SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. UPON RECEIVING THE RESULT, THE CLINICIAN ASKED THE PATIENT TO GO TO THE EMERGENCY ROOM. AT THE EMERGENCY ROOM, THE PATIENT WAS TESTED FOR TROPONIN I USING AN ABBOTT ARCHITECT ANALYZER. A NEW SAMPLE WAS OBTAINED FROM THE PATIENT FOR THE TROPONIN T AND TROPONIN I ASSAYS. THE REPORTER RECALIBRATED THE TROPONIN T ASSAY AND RERUN THE SAMPLE. THIS SAMPLE WAS ALSO SENT OUT TO A SISTER FACILITY THAT ALSO USES A ROCHE ANALYZER AND AN ABBOTT ARCHITECT ANALYZER FOR THE TROPONIN T AND TROPONIN I ASSAYS RESPECTIVELY. ON (B)(6) 2021 AT 9:00 PM, THE TROPONIN T INITIAL RESULT FROM THE E 602 MODULE WAS 4.1 NG/ML. THE TROPONIN I INITIAL RESULT FROM THE ABBOTT ARCHITECT WAS <0.01 (THE UNIT OF MEASUREMENT WAS NOT SPECIFIED). THE REPORTER STATED THAT THIS TROPONIN T RESULT DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENT; THEY BELIEVED THAT THE TROPONIN I WAS THE ACCURATE RESULT. ON (B)(6) 2021 AT 9:00 AM, THE TROPONIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13358383 ↗
• MalfunctionJul 14, 2021Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TROPONIN T STAT ASSAY RESULTS FOR THREE PATIENTS TESTED ON A COBAS 6000 E 601 MODULE SERIAL NUMBER (B)(4). THE INITIAL TROPONIN RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PERFORMED REPEAT TESTING WITH THE SAMPLES ON A DIFFERENT COBAS 6000 E 601 MODULE. AT 19:45, PATIENT 1'S INITIAL TROPONIN RESULT WAS 0.04 NG/ML. AT 20:33, PATIENT 1'S REPEAT TROPONIN RESULT WAS 0.02 NG/ML. AT 19:46, PATIENT 2'S INITIAL TROPONIN RESULT WAS 0.04 NG/ML. AT 20:33, PATIENT 2'S REPEAT TROPONIN RESULT WAS 0.01 NG/ML. AT 20:33, PATIENT 3'S INITIAL TROPONIN RESULT WAS 0.04 NG/ML. AT 20:33, PATIENT 3'S REPEAT TROPONIN RESULT WAS 0.01 NG/ML. THE CUSTOMER DETERMINED THE REPEAT TROPONIN RESULTS WERE CORRECT AND CORRECTED REPORTS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12165318 ↗
• MalfunctionAug 17, 2018Non Reproducible Results; Non Reproducible Results

  A ROCHE REPRESENTATIVE HAD BEEN AT THE CUSTOMER SITE TO PERFORM TECHNICAL TASKS ON MULTIPLE ANALYZERS INCLUDING THIS COBAS 6000 E 601 MODULE. THE ELECSYS TROPONIN T STAT ASSAY (TROPONIN T STAT) HAD BEEN REMOVED FROM THE MODULE DURING THIS TIME REQUIRING THE CUSTOMER TO RECALIBRATE AND RUN QC ONCE IT WAS PUT BACK ON. THE CUSTOMER THEN BEGAN TESTING PATIENT SAMPLES. AT APPROXIMATELY 5:15 P.M. THE LABORATORY WAS NOTIFIED THAT A TREND HAD BEEN NOTICED FOR TROPONIN T STAT RESULTS FOR PATIENT SAMPLES. ALL TROPONIN T STAT RESULTS WERE EITHER 0.04 NG/ML OR HIGHER WHEN THE EXPECTED RESULTS WERE 0.01 NG/ML OR BELOW. THE CUSTOMER STOPPED RUNNING PATIENT SAMPLES AND RAN QC WHICH WAS OUTSIDE OF THE ACCEPTABLE RANGE. THE CUSTOMER STATED 23 PATIENTS HAD BEEN RUN AND TROPONIN T STAT RESULTS HAD BEEN REPORTED OUTSIDE OF THE LABORATORY BETWEEN 11:30 A.M. AND 12:00 P.M. THE CUSTOMER STARTING REPEATING AND CORRECTING PATIENT RESULTS BETWEEN 5:30 P.M. AND 10:00 P.M. REFER TO ATTACHED DATA FOR PATIENT RESULTS. THE CUSTOMER MADE NEW CALIBRATOR MATERIAL AND RECALIBRATED THE ASSAY. AFTER RECALIBRATING, THE QC RESULTS WERE WITHIN RANGE. THE CUSTOMER WAS NOT AWARE OF ANY PATIENTS BEING TREATED BASED ON THE I

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7792859 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082699. One submission often covers many models, so check the product and lot details in each record.

• Z-1596-2021 · Apr 7, 2021 · Open, Classified
  Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
• Z-1595-2021 · Apr 7, 2021 · Open, Classified
  Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
• Z-1388-2012 · Mar 12, 2012 · Terminated
  Elecsys Troponin I STAT Immunoassay For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagn
• Z-1387-2012 · Mar 12, 2012 · Terminated
  Elecsys Troponin I Immunoassay For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis